Sharmin Aktar

About Sharmin Aktar

Accomplished Senior Scientist with a Ph.D. in Biophysical Chemistry and extensive experience in method development, validation, and troubleshooting for complex drug formulations and substances. Proficient in advanced analytical techniques, including HPLC, GC, UV/Vis spectrophotometry, and wet chemistry. Expertise in formulation development, analytical method transfer, and regulatory compliance, ensuring the successful scale-up of drug products and enhancing lab efficiency.I specialize in driving process optimization, supporting regulatory submissions, and ensuring compliance with cGMP, GLP, FDA, and ICH guidelines. Throughout my career, I have led projects related to both small molecule and protein-based drug formulations, and contributed to cross-functional teams, providing analytical and formulation support for R&D and manufacturing, while mentoring junior scientists.My skills span pharmaceutical R&D, formulation design, protein purification, method transfer, and regulatory submissions. I am passionate about advancing scientific innovation and dedicated to contributing to the development of life-enhancing pharmaceutical products.

Experience

1. Senior Scientist

   Biolink Life Sciences

   May 2024 — Present · Cary, NC, US

   Method Development and Validation: Spearheaded the development, validation, and troubleshooting of analytical methods for characterizing drug substances and products using HPLC, GC, and UV/Vis spectrophotometry, ensuring compliance with cGMP, FDA, and ICH guidelines.• Formulation Development Oversight: Led the formulation team to design, develop, and optimize drug formulations, aligning with project timelines and regulatory standards.• Quality Assurance and QMS Oversight: Monitored and ensured compliance with Quality Management Systems (QMS), implementing process improvements to enhance laboratory operations.• Data Analysis and Reporting: Authored detailed technical reports and reviewed analytical data to support regulatory submissions and maintain data integrity.• Collaboration: Partnered with cross-functional teams, including formulation and manufacturing, to streamline workflows and support product scale-up.• Mentorship: Trained and mentored junior scientists, fostering technical skill development and improving team productivity by 30%.• Innovative Problem-Solving: Implemented analytical solutions and process optimizations that enhanced laboratory efficiency by 20%, improving overall data accuracy.

Education

• State University of Bangladesh

  Master in Pharmacy

  2016 — 2017

• State University of Bangladesh

  Bachelor of Pharmacy - BPharm

  2012 — 2015

• North Carolina State University

  Doctor of Philosophy - PhD

  2019 — 2024